The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Qms Lamotrigine Assay (reagents), Calibrators & Controls.
| Device ID | K062966 |
| 510k Number | K062966 |
| Device Name: | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS |
| Classification | Lamotrigine Assay |
| Applicant | SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
| Product Code | ORH |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2007-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883012684 | K062966 | 000 |
| 00884883011274 | K062966 | 000 |
| 00884883011267 | K062966 | 000 |
| 00884883011168 | K062966 | 000 |